Drug Safety Associate

2-4 years

Not Disclosed

Bangalore

10 March 2, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Drug Safety Associate

Company: Novotech

Experience: 2 - 4 Years

Location: Bangalore

Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences

Posted On: February 21, 2025

Job Type: Verified Job

Application Mode: Online Application

Job Highlights:

Work/Life Balance
Time Management
Challenging Projects
Insurance

Job Description:

Novotech is seeking a Drug Safety Associate for its Bangalore location. This role focuses on pharmacovigilance, ensuring drug safety in clinical trials and post-marketing surveillance. Candidates will be responsible for monitoring safety data, processing adverse event reports, and maintaining regulatory compliance.

Key Responsibilities:

Project Management: Prepare safety management plans, set up safety databases, and create project kick-off materials.
Case Processing: Draft safety narratives, monitor safety mailboxes, and maintain Trial Master File (TMF) documentation.
Regulatory Compliance: Ensure timely submission of safety reports to regulatory agencies.
Collaboration: Work closely with medical monitors, drug safety physicians, and study teams.
Training: Mentor junior staff and support team development.
Other Responsibilities: Conduct literature searches for adverse events and support audits.

Eligibility Criteria:

Education & Experience:

Degree in Nursing, Pharmacy, or Health/Biomedical Sciences (postgraduate qualifications preferred).
2-4 years of experience in pharmaceuticals or CROs, focusing on safety in clinical trials.

Skills Required:

Strong knowledge of pharmacovigilance and clinical trial regulations (ICH-GCP, SOPs).
Familiarity with medical coding (e.g., MedDRA) and safety databases.
Excellent English communication skills with the ability to summarize medical data.
Strong time management and multitasking skills.

Why Join Novotech?

Novotech is a global leader in biotech and clinical research, with 34 offices worldwide and over 3,700 clinical projects. The company offers:

Flexible work hours
Paid parental leave
Wellness programs
An inclusive workplace supporting LGBTIQ+ individuals, people with disabilities, and caregivers
ISO 27001 and ISO 9001 certifications ensuring high-quality standards

Industry Outlook:

Pharmacovigilance in India is rapidly growing, with the market expected to expand at a CAGR of 11.5% through 2030. This makes it an excellent time to pursue a career in drug safety.

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Drug Safety Associate

Job Description

Job Highlights:

Job Description:

Key Responsibilities:

Eligibility Criteria:

Education & Experience:

Skills Required:

Why Join Novotech?

Industry Outlook:

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